This Healthcare Tech Company Has Become The First To Receive FDA De Novo Authorization For An OTC COVID-19 Test | News Direct

This Healthcare Tech Company Has Become The First To Receive FDA De Novo Authorization For An OTC COVID-19 Test

News release by Benzinga

facebook icon linkedin icon twitter icon pinterest icon email icon Detroit, Michigan | August 18, 2023 09:00 AM Eastern Daylight Time

By Rachael Green, Benzinga

The healthcare technology company Cue Health Inc. (NASDAQ: HLTH) has become the first company to get De Novo authorization from the U.S. Food and Drug Administration (FDA) for an over-the-counter COVID-19 test — as well as being the first FDA De Novo authorization for any over-the-counter molecular test for a respiratory disease. The Cue COVID-19 Molecular Test is designed for both at-home and point-of-care use.

Cue Health was also previously the first company to receive an Emergency Use Authorization (EUA) from the FDA for an at-home molecular diagnostic test available without a prescription, which helped the company rake in over $1 billion in revenue over two years from both public (government entities) and private (point-of-care, enterprise, and direct-to-consumer) customers because it is highly accurate and has an easy-to-use design.

There are still an average of over 2,000 patients with COVID-19 admitted to hospitals every day in the United States. For both the flu and COVID-19, early diagnosis and treatment are critical to preventing serious illness and even death.

In March, the FDA recommended to manufacturers that had received EUAs for their COVID-19 tests to submit new applications and meet the requirements for full clearance in order to keep selling their products.

Cue has already achieved that new FDA authorization for its COVID-19 test., and it also has an EUA under FDA review for its Flu A/B + COVID-19 multiplex test, plus additional requests for De Novo classification under review including for its standalone flu test and its respiratory syncytial virus (RSV) test. The company already has an EUA for its molecular test to detect the monkeypox virus.

The at-home and point-of-care COVID-19 tests deliver lab-quality results to connected mobile smart devices in about 20 minutes. The test integrates into Cue Care, the company's state-of-the-art test-to-treatment service where patients can connect with a healthcare provider through the Cue Health App to discuss their results, form a treatment plan and have prescribed medications delivered straight to their door.

COVID-19 Diagnostics Market Remains As The Disease Becomes Endemic

Cue’s De Novo authorization comes as public health officials and epidemiologists have been continuously reporting that COVID-19 has transitioned from pandemic to endemic. Similar to the flu, COVID-19 cases will likely continue to cycle between highs and lows, but in a relatively more predictable manner. Movement into endemic status only means that testing will be even more important and needed over a much longer period of time.

 Early diagnosis of a respiratory illness can potentially lead to a milder infection and a decreased likelihood of hospitalization. Maintaining vigilance in preventing infection and opting for early detection and treatment at the first sign of symptoms (especially in households with children, senior citizens, family members with disabilities, or other at-risk individuals) can be crucial, especially for COVID-19.

Cue Health’s diagnostic platform is able to help both patients and care providers stay ahead of COVID-19 over the long term, as the disease enters its endemic stage. By providing fast and accurate results, the platform could help minimize the spread of the disease and the risk of hospitalizations.

Cue’s Molecular Diagnostic Platform — A Game Changer For Testing

Cue’s test is a NAAT (Nucleic Acid Amplification Test) that amplifies and detects the virus’s RNA. Because it can amplify the genetic material, Cue’s test is much more sensitive than an antigen test. In clinical studies, the Cue COVID-19 Molecular Test matched three FDA-authorized, lab-based PCR tests with 98% accuracy. The company’s innovative technology turned the complex test into a user-friendly kit that requires no advanced training.

Cue’s molecular test is proven to deliver accurate results even in the early days after exposure whereas antigen results are not nearly as reliable. This is important as, according to the CDC, treatment must be started within days after you first develop symptoms to be effective. Cue's molecular test, which delivers results in 20 minutes, is also much faster than a PCR test, which can take anywhere from 12 hours to five days.

The test can be used on adults or children with or without signs or symptoms of COVID-19 and it is self-contained, meaning it doesn’t involve mixing fluids or running an involved testing procedure. Users simply insert the cartridge into their Cue Reader, collect a nasal sample with a Cue Sample Wand, and insert the Wand into the cartridge. About 20 minutes later, results are sent to the Cue Health App on the user’s phone.

With its head start in the transition from EUA to permanent market authorization for its at-home COVID-19 molecular test and a slate of additional at-home tests compatible with the same Cue Reader device, analysts have expressed optimism about the healthcare tech company’s future earnings potential.

This document may depict certain future planned care offerings which are subject to completion of development and/or may require regulatory authorization, clearance, or approval before they can be commercialized.


This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.


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